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Clinical Trials/NCT04634929
NCT04634929
Recruiting
N/A

Changes in Endocrinological and Central Neuronal Satiety Regulation Following Bariatric Surgery

University of Heidelberg Medical Center1 site in 1 country60 target enrollmentDecember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Bariatric Surgery
Sponsor
University of Heidelberg Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Change in Functional magnetic resonance imaging following intravenous glucose infusion.
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
February 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Heidelberg Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Joe Simon

Principal Investigator

University of Heidelberg Medical Center

Eligibility Criteria

Inclusion Criteria

  • planning to undergo bariatric surgery
  • planning to take part in a conservative diet

Exclusion Criteria

  • inability to undergo fMRI
  • psychiatric disorders
  • metabolic disorders

Outcomes

Primary Outcomes

Change in Functional magnetic resonance imaging following intravenous glucose infusion.

Time Frame: 2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.

Change in responsivity of the hypothalamus (extracted as percent signal change) as the core region of homeostatic control will be assessed after an intravenous glucose infusion (by calculating the area under the curve of hypothalamic responsivity) before and after bariatric surgery or dietary intervention.

Assessment of glucose-induced changes in peripheral ghrelin using blood samples.

Time Frame: 15 minutes before and 15 minutes after functional magnetic resonance imaging

Blood is collected to measure the concentration of peripheral ghrelin as an indicator of hormonal satiety signaling. Blood samples are collected at the beginning and end of each experimental session to assess the influence of intravenuous infusion of glucose on ghrelin signaling. Blood samples will be analysed using using commercially available kits (enzyme-linked immunosorbent assay).

Experimental functional magnetic resonance imaging task (gustatory stimulation).

Time Frame: 2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.

Neuronal gustatory processing of food stimuli will be assessed (ingestion of sweet liquids using a gustometer) using a general linear model (comparing brain activation during ingestion of sweet liquids with brain activation during the ingestion of water) and within as well as between groups analyses. Changes in neural gustatory processing of food stimuli will be assessed before and after bariatric surgery or dietary intervention.

Study Sites (1)

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